Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device injector, vertebroplasty (does not contain cement)
Definition Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product CodeOAR
Regulation Number 888.4200
Device Class 1

MDR Year MDR Reports MDR Events
2014 12 12
2015 8 8
2016 9 9
2017 22 22
2018 11 11
2019 14 15
2020 5 11
2021 13 24
2022 11 14
2023 14 17
2024 15 20

Device Problems MDRs with this Device Problem Events in those MDRs
Break 50 51
Fracture 31 57
Adverse Event Without Identified Device or Use Problem 16 16
Device Operates Differently Than Expected 8 8
Fluid/Blood Leak 7 7
Difficult to Remove 5 5
Use of Device Problem 5 5
Detachment of Device or Device Component 4 6
Entrapment of Device 3 3
Failure to Eject 3 3
Leak/Splash 2 2
Material Integrity Problem 2 2
Material Fragmentation 2 2
Material Separation 2 2
Chemical Problem 1 1
Torn Material 1 1
Unsealed Device Packaging 1 1
Contamination /Decontamination Problem 1 1
Delivered as Unsterile Product 1 1
Retraction Problem 1 1
Activation Failure 1 2
Appropriate Term/Code Not Available 1 1
Improper Chemical Reaction 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 68
Foreign Body In Patient 29 51
No Consequences Or Impact To Patient 21 23
No Known Impact Or Consequence To Patient 19 21
Device Embedded In Tissue or Plaque 9 9
Insufficient Information 7 10
Nerve Damage 6 6
No Code Available 5 5
No Patient Involvement 3 3
Non-union Bone Fracture 3 3
Joint Laxity 3 3
Unspecified Tissue Injury 3 3
Impaired Healing 2 2
Blood Loss 2 2
Osteolysis 2 2
Extravasation 2 2
Embolism 2 2
Therapeutic Effects, Unexpected 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Bone Fracture(s) 1 1
Pain 1 1
Sedation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jul-03-2012
2 Medtronic Sofamor Danek USA Inc II Jan-14-2018
3 Medtronic Sofamor Danek USA Inc II Jun-03-2017
4 Merit Medical Systems, Inc. II May-21-2020
5 Orthovita, Inc., dBA Stryker Orthobiologics. II May-24-2013
6 Stryker Corporation II Jul-03-2024
7 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
8 Synthes USA HQ, Inc. II Nov-27-2013
-
-